Status:
UNKNOWN
Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH
Lead Sponsor:
Livzon Pharmaceutical Group Inc.
Conditions:
Oligospermia
Azoospermia
Eligibility:
MALE
25-35 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia.
Eligibility Criteria
Inclusion
- Male subjects aged 20\~35.
- They accorded with diagnostic criteria of severe oligospermia or azoospermia.
- They had'nt been treated with drug which could improve sperm count and quality one month before observation，otherwise,they should have a elution for 1 month before the study.
Exclusion
- Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma hominis were detected in their semen.
- Subjects addicted to drug，tobacco，or alcohol.
- Subjects had heat,chemicals,radioactive material,or toxic contact history within a year.
- Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic drugs,or nonsteroidal anti-inflammatory drugs .
- Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease.
- Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for infertility .
- Subjects did not meet the inclusion criteria, did not according to the prescribed medication, were unable to judge the efficacy ,had incomplete information, or affected the efficacy or safety judgment.
- Subjects were IHH patients
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02307994
Start Date
August 1 2014
Last Update
December 8 2014
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China, 100191